Prescription drug · ANDA
Galantamine Hydrobromide NDC 47335-836
Galantamine hydrobromide 16 mg/1 · Capsule, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-836-08 | 47335083608 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-08)Marketed from Feb 9, 2011 | |
| 47335-836-18 | 47335083618 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-18)Marketed from Feb 9, 2011 | |
| 47335-836-83 | 47335083683 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-83)Marketed from Feb 9, 2011 | |
| 47335-836-88 | 47335083688 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-88)Marketed from Feb 9, 2011 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Galantamine Hydrobromide
- Generic name (nonproprietary)
- galantamine hydrobromide
- Active ingredients
- Galantamine hydrobromide — 16 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090178
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-836_3ddec6e9-e082-4c2d-a026-aee87736ef80SPL ID 3ddec6e9-e082-4c2d-a026-aee87736ef80SPL set ID d1697161-ebe8-42b0-83e7-c9de4412546cRxCUI 860695, 860707, 860715UNII MJ4PTD2VVWUPC 0347335835830
- Pharmacologic class
- Cholinesterase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N447335083608followed by a unit qualifier and the quantityPackage 47335-0836-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 47335-836
- What is NDC 47335-836?
- 47335-836 is the product NDC for Galantamine Hydrobromide, Galantamine hydrobromide 16 mg/1 capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Galantamine Hydrobromide.
- What is the active ingredient?
- Galantamine hydrobromide.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Galantamine Hydrobromide?
- 9 other product NDCs are listed under this name. See all Galantamine Hydrobromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Galantamine Hydrobromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-835 | 47335-0835-0847335-0835-1847335-0835-83+1 more |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-837 | 47335-0837-0847335-0837-1847335-0837-83+1 more |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2363 | 63629-2363-01 |
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2364 | 63629-2364-01 |
| Galantamine Hydrobromide | Galantamine hydrobromide 16 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2365 | 63629-2365-01 |
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1446 | 72162-1446-03 |
| Galantamine Hydrobromide | Galantamine hydrobromide 16 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1447 | 72162-1447-03 |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1448 | 72162-1448-03 |
| Galantamine Hydrobromide | Galantamine hydrobromide 4 mg/mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0137 | 00054-0137-49 |
Other NDCs under ANDA 090178
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-835 |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-837 |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2363 |
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2364 |
| Galantamine Hydrobromide | Galantamine hydrobromide 16 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-2365 |
| Galantamine Hydrobromide | Galantamine hydrobromide 8 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1446 |
| Galantamine Hydrobromide | Galantamine hydrobromide 16 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1447 |
| Galantamine Hydrobromide | Galantamine hydrobromide 24 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 72162-1448 |